50 of these patients will receive a total hip replacement; 50 patients will receive a total knee replacement;

Device: Prevena Incisional Management System

All evaluable patients will utilize the Prevena Incisional Management System

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Subject must be ≥ 18 years of age

Subject must, at the treating physician's determination and definition, be an appropriate Candidate for primary total hip or knee arthroplasty

Subjects who undergo primary total knee or hip arthroplasty must have a linear or semi-linear incision whose length and curvature should fit within the dimensions bound by the polyurethane foam (10 inches in length by 2.5 inches in width)

Subject is able and willing to provide written informed consent and comply with visit schedule

Subject must agree to avoid application of tanning lotions or exposure of ultraviolet radiation from sun or artificial sources such as a tanning bed on operative area for the duration of study participation

Subject must not be pregnant if of child-bearing potential, or otherwise must be surgically sterilized or unable to conceive. All females, regardless of child-bearing potential, will receive a urine hCG test 2 weeks prior to surgery and the test result must be negative for pregnancy.

Subjects who are of child-bearing potential must be utilizing an acceptable method of birth control (eg, birth control pills, condom with spermicide, diaphragm with spermicide, implants, IUD, injections, vaginal rings, hormonal skin patch, etc) and be willing to continue birth control for duration of study participation. If birth control method is the form of birth control pills, shots, implants skin patches, or IUD, the method must have been utilized for at least 30 days prior to study participation.

Subject must be willing to wear loose fitting clothing for duration of treatment period

Subject must be willing to comply with visit schedule for the duration of the study

Exclusion Criteria:

Positive pregnancy test confirmed by hCG in urine

Current or past (30 days prior to surgery) within time of screening attempts to become pregnant

Current or past (14 days prior to surgery) within time of screening topical treatments on operative area (eg, laser hair or tattoo removal, sunless tanning lotions)

Current or past (14 days prior to surgery) steroid topical therapies on operative area

Current or past (30 days prior to surgery) use of oral steroids (NOTE: Use of non-topical, ophthalmic or aerosol types of steroids (ie, inhaled corticosteroids) are permitted at screening and throughout the clinical trial)

Current or past (72 hours prior to surgery) within surgery use of antihistamines

Current or past (30 days prior to surgery) within time of screening use of oral Tetracycline or AcutaneTM or topical Tetracycline or AcutaneTM on the operative area

Presence of skin lesions or abnormalities on operative area

Current or past malignancy requiring immunosuppressant therapy or chemotherapy within 5 years within time of screening

Presence of excessive skin folds on operative area

Intentional exposure of the operative area to ultraviolet radiation (14 days prior to surgery) within time of screening (ie, sunbathing or tanning bed)

Presence of sunburned or peeling skin on operative area

Tattoos on operative area

Presence of severe, raised scar tissue on operative area which may interfere with pre and post skin evaluation assessments

Presence of an open wound prior to the index surgical procedure on operative area

Topical hypersensitivity or allergy to any disposable components of the dressing system (eg, silver, polyurethane, polyester, or acrylic adhesive)

Topical hypersensitivity or allergy towards any medical adhesive

Current enrollment or past participation in this clinical study or any other study within ≤30 days

Any systemic or local active dermatological disease that might interfere with the evaluation of the operative area (eg, Meleney's ulcer, scleroderma, chronic urticaria, psoriasis, skin cancer, eczema, seborrhea, or malignancy)

Subjects in whom the index procedure is a revision of a total hip or knee arthroplasty

Subjects in whom the primary or partial total hip or knee arthroplasty would also be performed on the contra lateral knee or hip at the same time

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.